Cachexia in Advanced NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional Implications and Validation of Skeletal Muscle Disfunction Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival in cachectic and non-cachectic patient
研究概览
简要总结
LUCAX01 is a cohort study with patients with advanced NSCLC in tobacco users. in this study, patients will be submitted to baseline physical tests, blood and biopsy sample collection, and the main objective is to study the functional and prognostic implications of cachexia and to validate skeletal muscle dysfunction markers.
详细描述
Non-small-cell lung cancer (NSCLC) is currently the neoplasm leading in deaths worldwide and in Brazil, it figures as the second most common cancer in terms of the number of deaths. Patients are usually diagnosed in advanced stages and, consequently, more than 45% of all patients are diagnosed with cachexia. This syndrome is characterized by a loss of muscle mass with or without fat loss and it cannot be reversed by nutritional support. In the physiopathology of cachexia, generally are present exacerbated inflammation, severe loss of muscle contractile proteins, leading to fatigue and increased mortality. Furthermore, patients with cachexia usually do present lower response rates to anticancer treatments and it is also associated with a worse overall prognosis.
Treatments directed to mitigate muscle loss in these patients are awaited. Cohort studies do suggest a significant positive impact of physical fitness and prognosis in different chronic diseases; however, its impact in advanced NSCLC patients is not clear. Here our aim is to better understand the relationship between cachexia and physical fitness variables (muscle and cardiorespiratory function, body composition, and daily physical activity level) with prognosis and mortality in a group of NSCLC patients, as well as to study the effect of chemotherapy on these variables. Besides that, will be evaluated the skeletal muscle, Treg lymphocytes, and inflammatory biomarkers and compare cachectic and non-cachectic patients.
Sixty NSCLC patients will be accrued. Will be assessed the maximum oxygen consumption, daily physical activity, muscle function, muscle morphology, anxiety, depression, performance status, and fatigue pre-treatment. Blood and muscle biopsy samples will be collected. The prognostic impact of these physical fitness variables will be defined, as well as their predictive value in terms of response to anticancer treatments in advanced NSCLC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced stage IVa or IVb NSCLC patients histologically diagnosis.
- •Eastern Cooperative Oncology Group Performance status 0 - 2
- •Treatment-naive
- •Current smokers or ex-smokers
- •Normal renal, hepatic and hematological functions
- •Able to perform the physical functional tests
- •Able to read and sign the consent form
排除标准
- •Initiate treatment before initiate
- •Diagnostic of tumor mutation ( epidermal growth factor receptor, Anaplastic lymphoma kinase)
- •Obs: A smoker population with no known cancer will be used as controls (n=10)
结局指标
主要结局
Overall survival in cachectic and non-cachectic patient
时间窗: 2 year
Survival will be measured to understand the prognostic impact of cancer cachexia in NSCLC patients.
次要结局
- Physical fitness and response to treatment(1 year)
- Cancer cachexia skeletal muscle pathways(1 year)
- Cluster of Differentiation 4+ (CD4+) population in cachectic and non-cachectic patient.(1 year)
- Physical fitness and toxicity(1 year)
- Cluster of Differentiation 25+ (CD25+) population.(1 year)
- Forkhead box P3 regulatory T (Fox-p3+) population.(1 year)